The present disclosure relates to improved methods and apparatus for use in mandibular repositioning. More particularly, the present inventions relate to creating a custom fitted mandibular repositioning appliance that is easily adjustable and customized while reducing tissue impingement that may otherwise compromise airway space and/or architecture. The inventions"" consist of manners of attachment situated between the mandible and maxillary bite block or occlusal plains permitting structural stability and integrity allowing for user comfort and mobility as never before addressed or available. Furthermore, the attachment means element allows for infinite horizontal and vertical adjustability within the dimensions of the appliance and its attachment means. The novelty of this invention stems from the attachment means used and the location thereof.
The inventions relate to therapy in the treatment of sleep apnea, snoring, bruxism, and other now known or future diagnosed oral, respiratory, dental and developmental disorders that may affects the dentition and surrounding skeletal and muscular structures. In particular, the present inventions relate to improved methods and apparatus for enhanced precision and control of interocclusal devices used in patient therapy.
Difficulty in breathing while sleeping often manifests itself as snoring or the more serious obstructive sleep apnea. Snoring is a condition affecting approximately forty percent (40%) of the adult population, while sleep apnea is believed to affect at least twenty (20) million people.
In turn, bruxism consists of a static and/or dynamic contact between the dentition of the mandible and maxilla. Bruxism is commonly referred to as xe2x80x9ctooth grindingxe2x80x9d which results in the physical destruction of tooth enamel directly leading to tooth decay as well as more serious problems. Bruxism affects nearly fifteen percent (15%) of the population and in advanced stages bruxism results in the abnormal and excessive grinding or clenching of teeth while an individual is asleep. Bruxism is medically classified as parasomnia or sleep disorder. In some instances a person may be so unaware of the problem that it may occur while awake. As the individual may not be conscious of the problem, if bruxism becomes a habit it may become even more difficult to treat.
The actual cause of bruxism is not clear, however reference has been made to causes being related to emotional stress or other psychological factors. Common treatments range from psychotherapy, sedatives or tranquilizers and may further include bio-feedback, i.e. electrodes being taped to the jaw.
In turn, temporomandibular joint syndrome (or dysfunction) (xe2x80x9cTMJxe2x80x9d) is a disorder effecting the joint between the lower jaw and the skull. The temporomandibular joint lies between the temporal bone of the skull and the mandible of the jaw, and allows the jaw to open and close. The joint is formed by a condyle on the mandible which hinges and glides in and out of the depression in the temporal bone.
TMJ can be caused by bruxism, malocclusion, trauma, and arthritis. There is also an indication that a posterior or backward displacement of the condyle of the jaw significantly contributes to TMJ pain. TMJ has been associated with a wide variety of physical aliments, including migraine headaches. TMJ related headaches can become so severe as to cause nausea and blurred vision. Most people afflicted with TMJ suffer from a myo-facial pain-dysfunction syndrome primarily as a muscle problem related to dental/skeletal relationships and tensional factors. The effects can range from mild to severe, including pain in the joint area that can extend to the shoulders, back, neck, and sinuses. As a treatment, surgery is only utilized in the most severe cases, which represent approximately ten percent (10%) of those seeking treatment.
Accordingly, the medical profession and related health care industries have now begun to recognize the paramount importance of developing new and innovative techniques that effectively address one (1) or all of the aforementioned maladies. Therein, oral appliances (interocclusal devices) have been employed to prevent the tongue and/or collapse of oral pharyngeal tissue from obstructing the airway. To date, when used in the treatment of snoring or sleep apnea, these prior techniques and devices have been either unsuccessful, met with limited success or have resulted in undesirable side effect(s).
In a paper entitled Dental Appliances for the Treatment of Snoring and/or Obstructive Sleep Apnea, by Alan A. Lowe published in Principles and Practice of Sleep Medicine, W. B. Saunders Company, Second Edition 1994, chapter 69, pp. 772-785, a number of commercially available or experimental devices known were described together with their inherent problems and advantages. Most of these devices manipulate the tongue or adjust the relative positions of the mandible to the upper jaw. The latter being more desirable because the less the tissue contact, the less the tissue irritation and damage.
Tongue devices such as U.S. Pat. No. 4,715,368, and Reissue No: 33,442, issued to George discloses an oral device preventing the closure of the breathing passage. The George device uses flanges to depress and constrain the tongue.
U.S. Pat. No. 3,132,647, to Corniello teaches keeping the air passage open by engaging and depressing the rear portion of the tongue while supporting a portion of the downwardly hanging soft palate. The Corniello device resembles the :upper portion of an athletic mouth guard, with a metal tongue depressor at the back.
U.S. Pat. No. 4,169,473, to Samelson describes a device for positioning within the mouth of a user to prevent snoring and nocturnal bruxism. The Samelson device has an integrally molded body providing dental engaging arches and a rearwardly-opening central socket for cooperating with the forward portion of the user""s tongue in a manner which draws the tongue forward in order to increase the oral-pharyngeal airway space.
U.S. Pat. No. 3,434,470, to Strickland functions to control the amount of air capable of passing through the mouth, either lessening the intake volume of air to an extent wherein the person is incapable of producing a snore, or shutting off completely the passage of air through the mouth. The limitations with these types of devices are in restriction of airflow, impedance and limited or hindered tongue mobility, and thus tend to interfere with normal swallowing patterns. Importantly, constraint(s) placed upon the tongue tends to be uncomfortable and thus discourage use, resulting in decreased patient use and limited effectiveness.
Conversely, the Herbst appliance is an oral device that attempted to realign the mandible and maxilla. The Herbst appliance, which is shown in German Patent No. 374,163, consists of a metal band placed around an upper molar and lower incisor tooth. The two (2) bands are interconnected by a telescopic member and exert an anteriorly directed force on the mandible. This device needs great strength to resist xe2x80x9cbreakagexe2x80x9d from lateral jaw forces. Whereas, another Herbst appliance uses retentive blocks rather than banding directly to teeth.
Other, similar telescopic devices include those shown in U.S. Pat. No. 3,618,214, to Armstrong, as well as many other similar patents. All of these devices teach required wires or braces for attachment to the patient""s teeth.
U.S. Pat. No. 4,901,737, issued to Toone exemplifies the prior devices. Toone discloses an intra-oral appliance for reducing snoring which repositions the mandible in an open and protrusive position as compared to the normally closed position of the jaw. The Toone appliance includes a pair of V-shaped spacer members formed from dental acrylic which extend between the maxilla an mandible to form a unitary mouthpiece.
U.S. Pat. No. 1,674,336, to King teaches an appliance for placement between the teeth of the user. The King device resembles an athletic mouth guard, and has upper and lower channels which receive the upper and lower teeth respectively. The channels are spaced apart so there is a central air passage between them. In use, the King device moves the lower jaw downward, not forward, and forward is the preferred placement of the mandible in relation to the maxilla.
In U.S. Pat. No. 5,365,945, issued to Halstrom an attempt was made at allowing for a limited degree of lateral movement. The device contained only one (1) point of attachment. Due to the size, location, and surrounding supportive material necessary to maintain the attachment means fixed in this implementation, the device impinges tongue space due to the frontal point of attachment and as a proximate result the airway architecture is altered.
U.S. Pat. No. 5,066,226, issued to Summer is comprised of a bi-lateral xe2x80x9cspring-likexe2x80x9d means for attachment. Finally, U.S. Pat. No. 5,409,017, issued to Lowe discloses a double threaded attachment means located in the palate area.
In turn, the inventions as disclosed in this application, and in its additional embodiments, proposes a much more compact and precise attachment means, thereby more effectively alleviating problems. Furthermore, the xe2x80x9cmicroxe2x80x9d scaling, the strength of titanium coupled with its novel designs, infinite adjustability over a range, lateral and protrusive adjustment overcomes the inadequacies of the other devices.
In conclusion, the prior devices"" shortcomings range from: 1) limited or no adjustability; 2) tissue impingement and irritation; 3) serious and or significant impingement of tongue space; 4) significantly or severely altering the airway""s architecture; 5) minimal patient comfort; 6) bulkiness; 7) little or no free range of motion, and 8) only minimally addressing and remedying that for which they were intended.
In turn, aside from professional xe2x80x9ccustomxe2x80x9d manufacture there is a need for xe2x80x9cmass-producedxe2x80x9d oral devices such that the costs associated with specific professional services directed to an individual user may be minimized while accomplishing the same goals and objectives addressed herein.
Therein, a means to achieve mass production include the ability for the user to adjust the mandible protrusion themselves and create their own custom formable mouthpiece through the use of a thermoplastic or similar material as described herein with or without the aid of a physician. Their exists several prior references which allude to the use of a formable thermoplastic or such polymeric material mouthpiece or mouth guard however fail to include operative means for mandibular protrusion. Accordingly, the following is a review of some oral devices potentially capable of being xe2x80x9cmass producedxe2x80x9d.
U.S. Pat. No. 5,031,638, issued to Castaldi, teaches a mouthguard formed from a blank which includes an inner layer, rigid core disposed adjacent to and coextensively with the core. Impressions of the user""s dentition are made in the inner and outer layers by heating the blank to a predetermined temperature range and subjecting the blank to bit pressure. The impressions are set and the finished mouthguard is formed by cooling the blank below the predetermined temperature range. The core is formed from a material having a softening temperature above the predetermined temperature range and therefore provides structural support for the inner and outer layers when the blank is heated to the predetermined temperature range and after the blank is cooled to form the finished mouthguard.
U.S. Pat. No. 5,152,301, issued to Kittelsen, et al., discloses a thermoplastic mouthguard having a xe2x80x9cU-shapedxe2x80x9d base with top and bottom side and upward inner lingual and outer labial walls forming a channel for the maxilla having posterior and anterior portions. Occlusal posterior pads are on the bottom side of the base along the posterior portions of the guard to space apart the anterior teeth of the lower jaw from the anterior portion of the bottom side of the xe2x80x9cU-shapedxe2x80x9d base and to lessen pressure and possible impact forces. A rigid framework tray is provided for assisting in heating the mouthguard and positioning and aligning the mouthguard for custom formation to the user""s mouth.
U.S. Pat. No. 5,339,832, issued to Kittelsen, et al., teaches a composite mouthguard having a flexible and tough, softenable thermoplastic mouthguard portion with a xe2x80x9cU-shapedxe2x80x9d base having upward inner lingual and outer labial walls extending from the base. A shock absorbing and attenuating non-softening, resilient, low compression, elastomer framework is embedded in the mouthguard portion to absorb, attenuate and dissipate shock forces exerted on the mouthguard during athletic activity.
U.S. Pat. No. 5,746,221, issued to Jones, et al., discloses a cold formable mouthguard that provides protection to the teeth, gums, jaw, and joints of the facial region to absorb and dissipate energy and thus minimizing further injuries. The mouthguard can be shaped to retain the contours of the teeth and mouth by simply placing the mouthguard into the mouth and biting down, without the need for first boiling to soften or other such shaping step.
These references all teach the use of a thermoplastic or other such polymeric material which may be custom molded by the user, but none teach or imply their use in the treatment of any type of oral, dental, maxillo-facial, pharyngeal, or other such disease or malady.
The need has therefore arisen for a dental appliance that treats the aforementioned maladies that may be custom manufactured or mass produced by which either embodiment is capable of maintaining the mandible in a preferred protruded position, while allowing for a limited degree of lateral and protrusive movement thus minimizing the negative effects of a static positioning of the: 1) teeth and related muscles and ligaments; 2) temporomandibular joint irritation or aggravation; 3) decreased impingement or disruption of tongue airway/architecture and flow, individually and in combination, and 4) rigid fixation of teeth to limit tooth movement and undesirable occlusal change. These and other objects and advantages of the present invention will become apparent from the following description and by reference to the accompanying drawings.
Methods and devices that allow for articulation and disarticulation and positioning of the mandible in relation to the maxilla is disclosed. Such movement and ranges of motion coupled with the unique and novel manners of attachment between the upper and lower relational members allow precise control of mandibular placement. Further, the precise positioning allows for a range of motion in static and functional use. Additionally, the ability to articulate and disarticulate allows for comfort in insertion and application in the patient""s mouth and allowing for divergent paths of insertion and withdrawal between the invention""s means for articulation. The device provides for infinite adjustability within the dimensions of the oral cavity.
What is disclosed are methods and devices that allow for the mandible to be retained in a position, determined by the physician, dentist, or like professional, in relation to the maxilla. Such mandibular positioning reduces the possibility of the airway collapsing and thus the related breathing disorders. In addition, fixation of the mandible is effective in reducing or eliminating the symptoms arising from bruxism and TMJ.
Disclosed herein are methods and devices that allow for the reduction of impingement of tongue and airway""s architecture. Additionally, the alleviation of tongue contact is established by means of either bi-lateral points of attachment or and anterior point of attachment placed interocclusally in either embodiment between the respective upper and lower bite block or occlusal plains. Furthermore, the ability to position the attachment means interocclusally avoids tongue crowding that has a direct negative effect upon the airways architecture directly resulting from the tongues xe2x80x9cunnaturalxe2x80x9d or altered positioning and/or posturing.
What is also disclosed are devices that allow for the opening of the oral airway in a manner comparable to auto-titration as described in CPAP and similar devices. This is accomplished by providing a limited range of protrusive movement while keeping the mandible and maxilla in a relative fixed position.
What is disclosed are methods and devices for treating snoring, obstructive sleep apnea and other afflictions by adjustably maintaining a patient""s mandible in a preferred position comprising the steps of, for example in several embodiment: 1)once the dentist or physician determines the therapeutic position for a particular patient, an appropriate mold is taken of the maxillary dentition and of the mandibular dentition for formation of the appliance template; 2) securing a first attachment means to the undersurface of the template""s upper bite block or occlusal plain, the first attachment means comprised of a series of means to accept and maintain an attachment element attached thereto; 3) securing or molding a second attachment means to an upper surface of the template""s lower bite block or occlusal plain, the second attachment means comprising an area to accept and maintain an attachment element within a cavity of the second attachment means, 4) determining the preferred degree of mandibular protrusion or positioning required to alleviate the patient""s maladies, and 5) affixing the relational members in said protrusion or position.
According to the principles disclosed herein are fitted and infinitely adjustable oral appliances for improving sleep disordered breathing and for the reduction of other maladies with a structural shell comprised of durable, light weight, semi-rigid, formable material. The structural shell will comprise opposed upper and lower members. In turn, in the embodiments each member has attachment means, affixed, attached or molded, on either its respective adjacent sides on opposing upper and lower surfaces of the bite block or occlusal plain. And in another embodiment, the anterior region of the upper and lower members, on opposing upper and lower surfaces of the bite block or occlusal plain. The attachment means is located on the surface directly above the crown of the tooth beneath the member such that the attachment means is affixed, molded or otherwise attached to or on the opposing bite block or occlusal plains, i.e., the upper and lower members. (Envision the surfaces of upper and lower teeth directly opposing each other. Therein there is a surface contact area between the teeth that when the teeth are in contact with each other would constitute the bite, now just expanded opposing teeth to multiple teeth and there is a xe2x80x9cbite block or occlusal plainxe2x80x9d. Now envision a manner for connecting the bite block or occlusal plains when they are not in direct contact with each other and then xe2x80x9cinsertxe2x80x9d a means for attachment or maintain a predetermined distance a relative constant, hence the attachment element.). The upper member, with respective attachment means, appropriately positioned, either bi-laterally or anteriorly, will in turn have an attachment element structurally affixed to it so as to allow for the upper members attachment to the lower member. The lower member is also comprised of an attachments means, appropriately positioned, either laterally or anteriorly, whereby an attachment means allows for initial attachment of the attachment element opening the airway and thus increasing the vertical position of the hyoid bone and therefore further effecting and optimizing the airway. Then upon advancing of the mandible the device is articulated, thus allowing lateral movement in its articulated position. In turn, a complete appliance, by ways of the attachment element and means, outwardly advances or positions the mandible forward with respect to the maxilla and by way of the positioning of the attachment means, either bi-laterally and posteriorly, or anteriorly, there is minimal impediment of the tongue or oral architecture as never before available.
The upper and lower members of the structural shell are molded from a dental impression and then appropriately fitted and adjusted for a custom fit. The members are preferably formed of flexite or other similar material. The material, e.g., flexite, presently available allows for the structural shell to be comprised of a more durable material able to sustain its structural integrity under the physical and chemical forces of the mouth, as never before possible. In turn, allowing for the equal distribution of lateral and vertical forces and minimum tissue or oral airway impingement due to the physical properties of the material and appliances"" design. In an alternate embodiment using user adjustable attachment means, said molds may be comprised of a material of similar properties as described above which may be custom cast or molded by the user in his or her own home. The shell may be created by injection mold processes, cold casting, or other like means known by those skilled in art with the attachment means xe2x80x9cpre-castxe2x80x9d, xe2x80x9cpre-moldedxe2x80x9d or xe2x80x9cpre-affixedxe2x80x9d for home use and modification. Such an embodiment allows for mass production and distribution of a xe2x80x9cuniversalxe2x80x9d snore reduction device.
The attachment means of the upper member is attached, molded, affixed or otherwise secured to or on the structural shell in the area that is otherwise xe2x80x9ccoveringxe2x80x9d the top or crown of the tooth or teeth, e.g., the opposing surface(s) of the bite block or occlusal plains, thus allowing for interocclusally, structurally sound and durable positioning. The attachment means are comprised of titanium or other material with similar properties. The attachment means may contain a beveled edge, allowing for its recessing into the upper member. The upper attachment means, in either the anterior or bi-lateral embodiment, may consists of track-like means having a recessed retaining nut or like retention means or attachment means molded directly into the member. The track allows the attending physician, dentist, like professional or individual to determine and fixedly position, non-discretely, any amount of mandible protrusion by the tightening of the attachment element into the retaining nut within the confines of the track-like means. Attached to the retaining nut is a screw or other attachment element comprised of titanium or like material. The head of the screw may be flat or concave at its distal end. The shaft may be completely threaded or otherwise. Alternatively, the attachment element may be comprised of two (2) flat head or concave surfaces connected by a shaft. Said screw or other attachment element mates with the lower attachment means. Additional manners and apparatuses may be utilized to accomplish the same and inasmuch will become obvious to one skilled in the art upon review of this disclosure.
The attachment means of the lower member(s) is attached, molded, affixed or otherwise integrated and secured to the structural shell thus allowing for structurally sound and durable positioning to or on the structural shell in the area that is otherwise xe2x80x9ccoveringxe2x80x9d the top or crown of the tooth/teeth, e.g., the opposing surfaces of the bite block or occlusal plains. The attachment means are comprised of titanium or other material with similar properties. The attachment means of the lower member comprises an opening or hole-like area that may or may not be threaded or other attachment components that allows for the positional attachment, movement and placement of an attachment element. The lower attachment means, in either the anterior or bi-lateral configuration, could consist of a track of lesser width than the head of the screw or other such attachment element. Said track features ample diameter to accept the head of the attachment element for initial attachment and then disarticulation of the oral appliance. The hole also comprises an area through which the shaft of the attachment element may pass. The hole also comprises an area where in the shaft may move laterally without the head passing therethrough during the oral appliance""s articulation. The hole has a beveled inside edge thus allowing for the head to the attachment element to slide or otherwise pass within the confines of the attachment means. Such mating mechanism can be alluded to a chain lock on a door. The length of the track on said lower attachment means allows the user some freedom in mandible protrusion with respect to the maxilla, but is limited by the fixed position of the retaining nut in said upper attachment means. Limited lateral movement of the mandible relative to the maxilla is possible due to the track in said lower attachment means having a width slightly greater than that of said screw""s or other attachment element""s shaft diameter.
Said anterior connecting means arrangement includes two embodiments. In one embodiment, said connecting means are oriented latitudinally. Such arrangement allows the attending dentist, physician, like professional or individual to fix lateral movement of the mandible, while allowing limited mandibular protrusion. This embodiment is useful in the treatment of bruxism and the other aforementioned maladies.
In another embodiment, said connecting means may be oriented longitudinally. Such arrangement allows the attending dentist or physician to fix mandibular protrusion, while allowing limited lateral movement of the mandible. This embodiment is useful in the treatment of snoring, sleep apnea, and other mentioned sleep disorders and maladies. In both embodiments, connecting means are located interocclusally on the opposing surface of the respective bite block or occlusal plains.
When the device is used and in position, the device provides necessary protrusive jaw movement sufficient to open the airway and eliminate snoring sounds. Additionally, the device provides an opening between the mandible and maxilla to permit an adequate airway.
Many other advantages and features of the present invention will become obvious to those familiar in the art with review and reference to the detailed description and accompanying drawings.
Thus, it is an object of the present invention to provide a interocclusal repositioning appliance that may be is custom or mass produced and therein fitted and easily adjustable for the treatment of sleep disordered breathing, bruxism etc., and other above mentioned maladies and afflictions.
Another object of the invention is to provide for a protrusive infinitely adjustable oral appliance within the dimensions of the oral cavity.
Yet another object of the invention is to provide for a vertically infinitely adjustable oral appliance within the dimensions of the oral cavity.
Another object of the invention is to provide a device of the type described which does not cause discomfort to the user or harm to the teeth, tongue, temporomandibular joint or gums during use.
Another object of the invention to provide an improved oral cavity device that can be used by persons to give relief from snoring and sleep apnea, and that provides for breathing through the mouth, nares or both.
Still another object of the invention is to provide a device of the type described which is of durable and reliable construction since therapy may be required for life.
Yet another object of the invention is to avoid and minimize alteration of the oral airways architecture.
Another object of the invention is to provide a device that minimizes, alleviates or eliminates tongue irritation or contact with an oral appliance or parts thereof.
Another object of the invention is to reduce or eliminate the impingement upon tongue space.
Another object of the invention is to aid in the treatment of TMJ disorders.
Still another object of the invention is to reduce or eliminate bruxism and its negative effects.
Another object of the invention is to permit for a range of protrusive motion to aid in swallowing.
Another object of the invention is to permit for a range of lateral motion.
Another object of the invention is to reduce or eliminate the impingement upon vestibular space.
Yet another object of the invention is to allow for infinite adjustability with in the confines of the device""s parameters.
Another object of the invention is to allow for precision placement of the mandible in relation to the maxilla.
These and other objects and advantages of the present invention will become apparent from the following description and by reference to the accompanying drawings.